Ethics booklet

Preface

The documents on research ethics contained in this booklet were approved by the Senate of the University of Ottawa in 1991. Responsibility for research has, in the meantime, been assigned to the Vice-Rector (Research); the texts have been modified accordingly. The first articulates guidelines for the ethical conduct of research and sets out procedures for dealing with allegations of misconduct. The second outlines the terms of reference of the University Human Research Ethics Committee. Both documents are valid for the University as a whole. However, some faculties have adapted them to meet their specific needs. To find out whether your faculty has developed specific guidelines, please check with the faculty secretariat.

Two other University of Ottawa committees deal with issues relevant to research: the Biohazards Committee and the Animal Care Committee. These committees report to the Vice-Rector (Research), from whose office their terms of reference may be obtained.

Guidelines for the Ethical Conduct of Research and Procedures for Investigating Misconduct

Preamble

The university community has always recognized the necessity for maintaining the highest ethical standards in the conduct of research. However, the emerging belief that universities are responsible for the guidance and conduct of their faculty and staff has prompted the University of Ottawa to develop guidelines setting out general principles that underlie the ethical conduct of research. This is viewed as a preventive measure which should also help to ensure the reliability and high quality of research.

Allegations of misconduct in research, though rare, must be dealt with effectively. Formal procedures are essential to determining how such allegations should be handled and also to protecting the rights of individuals, the University and any outside funding agency.

Definition of Terms

Research: work undertaken to acquire new knowledge or to study a particular question.

Publication: For the purpose of these guidelines, a publication is any book, journal article, technical or other report, research paper, whether in print, typescript or manuscript form, or taped electronically.

Research personnel

Principal investigator: the person who has ultimate responsibility for a research project. In the case of a project funded by an external or internal grant, the holder of the grant. In the case of a project that is not funded, the initiator of the project. The principal investigator is usually the supervisor of the research team (which may include other faculty members) and is usually a faculty member.

Research trainee: refers to any undergraduate or graduate student, post-doctoral fellow or clinical fellow engaged in a research project.

Research associate: refers to any professional assistant (usually the holder of a Ph.D. or the equivalent) working under the supervision of the principal investigator.

Research assistant: refers to technical personnel working under the direction of the principal investigator.

Immediate supervisor: the principal investigator is the immediate supervisor of all members of the research team. The immediate supervisor of the principal investigator may be Chairperson of the Department, the Director of the Institute, the Dean of the Faculty or the Vice-Rector (Research), as appropriate for the administrative function occupied by the principal investigator.

Research unit: a faculty, department, school, section or research institute, laboratory at the University or in affiliated institutions.

Guidelines for the Ethical Conduct of Research

The following recommendations serve as guidelines from which each department or unit will formulate its own set of specific procedures to ensure the quality and integrity of research. Alternatively, a department or unit may decide to formally adopt the University of Ottawa guidelines. The Faculty Council or the Executive Committee of the Faculty shall be the depository of these Faculty guidelines.

Supervision of research personnel

Careful supervision is in the best interest of the research personnel, the institution and the academic community. The complexity of research methods and the necessity for caution in interpreting data require an active role for the principal investigator. The principal investigator is ultimately responsible for supervision.

Recommendations

The responsibility for supervision of research personnel should be specifically assigned to a faculty member (usually the principal investigator) in each research unit.

The ratio of other research personnel, especially trainees, to principal investigators should be small enough to allow effective communication and continuous supervision of all aspects of the research.

The principal investigator should oversee the designing of research and the processes of acquiring, recording, examining, interpreting and storing data; simply editing publications is inadequate.

Collegial discussions among all research personnel in a research unit should be held regularly to contribute to the scholarly efforts of group members and to provide informal review.

The principal investigator should provide each new member of the research team with applicable governmental and institutional requirements for the conduct of studies involving human subjects, animals, radioactive or other hazardous substances or recombinant DNA, as appropriate, the unit's guidelines for ethical conduct of research as well as any other information which is directly relevant to the research activity (such as guidelines for use of archival documents).

Data Gathering, Storage, Retention

A common denominator in most cases of alleged research misconduct has been the absence of a complete set of verifiable data. The retention of accurately recorded and retrievable results is of utmost importance for the progress of scholarly inquiry and to enable a scholar to account for the results obtained in the research he or she has conducted.

Unless a contractual obligation to a sponsor contains special provisions to the contrary, research documentation and material products of all research carried out by members of the University of Ottawa are the property of the University (or a University of Ottawa affiliated institution or hospital research institute when the research is carried out on these premises).

Recommendations

Original primary data/evidence must be retained by the laboratory or unit in which they are generated. With the knowledge and authorization of the principal investigator, a member of the research team may make copies of the primary data for his or her own use, but the immediate supervisor and all collaborators must have free access at any time to all original data/evidence and products of the research. Authorization to make copies may not be withheld without valid reasons, which must be communicated in writing to the Dean of the Faculty or, in cases involving graduate students, to the Dean of the Faculty of Graduate and Postdoctoral Studies.

All primary data should be promptly recorded in clear, adequate, original and permanent form which should not leave the laboratory or unit at any time. These records must be kept for at least five years, unless determined otherwise by the immediate supervisor. All permanent records must remain in the research unit upon departure of the investigator from the University of Ottawa. Alternative arrangements for copies to be kept by the University instead of original records must be made with the immediate supervisor.

When a principal investigator leaves the University, arrangements for the safekeeping of records and/or products must be made with his/her immediate superior.

Provision of material products -- such as cell lines, bacterial clones, other specific organisms and substances, or software developed and prepared during research -- to third parties for non-commercial research purposes within or outside the unit should only be made with the approval of the principal investigator or the immediate supervisor. Consultation with the Office of Research Services is highly recommended. Commercialization or licensing of research results or products requires the approval of the Office of Research Services, and as applicable, the hospital research institute.

Authorship

Gradual diffusion of responsibility for multi-authored or collaborative studies has led in recent years to publications for which no single author was prepared to take full responsibility. Two critical safeguards in the publication of accurate and scholarly reports are the active participation of all co-authors in verifying the part of a publication that falls within their specialty areas and the designation of one author who is responsible for the validity of the entire publication.

Recommendations

The only responsible criterion for authorship is that the co-author has made a significant intellectual or practical contribution; the concept of honorary authorship is unacceptable.

All authors are expected to share in the responsibility for the scholarly content and reliability of a publication.

In case of a conflict between authors, all attempts should be made to resolve the matter informally. If unavoidable, mediation by the Chairperson of the Department, the Director of the research unit or the Dean of the Faculty of Graduate and Postdoctoral Studies or the Vice-Rector (Research) will be required.

Procedures for Investigating Reports of Misconduct in Research

Before making a formal allegation of misconduct, a person may wish to consult informally with the Dean of the Faculty, it being understood that this consultation will remain strictly confidential.

N.B. Until allegations are substantiated, it is imperative that all proceedings take place in the strictest confidentiality.

Misconduct includes:

Falsification of data: ranging from fabrication to deceptively selective reporting, including the purposeful omission of conflicting data which leads to the falsification of results.

Plagiarism:the representation of another's work as one's own.

Misappropriation of others' ideas: the unauthorized use of privileged information (such as violation of confidentiality in peer review), however obtained.

Any other practice that seriously deviates from those commonly accepted within the scholarly community for proposing, conducting or reporting research.

For members of the Association of Professors of the University of Ottawa (APUO), research fraud shall be considered a contravention of the article in the Collective Agreement entitled "Professional Ethics". The procedures to be followed in cases of alleged scientific misconduct are set out in the Collective Agreement.

In the case of students, the procedures set out in the Senate policies on academic fraud at the undergraduate and graduate levels shall prevail. These policies are attached hereto as Appendices A and B, respectively.

Steps to follow in the case of misconduct allegations toward a person who is not a member of the APUO nor a student:

The Initial report

The initial report of suspected misconduct may come from various sources within or outside of the University or affiliated institutions. It must be in writing; anonymous allegations will not be considered. On being apprised of the allegations, the Chairperson of the Department or the Section Head of the involved individuals will inform the Dean of the Faculty as soon as possible.

After a preliminary assessment of the nature of the allegations, the dean will apprise the individual(s) against whom the allegation has been made and ask them to respond to the allegation within ten working days. After examining the response the Dean will determine whether a review by the Investigative Committee is necessary and whether other authorities should be informed. Any consultation undertaken by the Dean of the Faculty at that point must be in strict confidence. If a review by an Investigative Committee is not warranted, the dean shall so inform the individual(s) concerned within five working days. If the Dean finds that there may be substance to the allegation, he or she will inform the Vice-Rector (Research) who will organize and chair a preliminary meeting which shall be attended by the Dean of the Faculty, the person(s) against whom the allegations were levied and, as appropriate, the Vice-Rector (Resources) or the Director of the Human Resources Service. The purpose of this meeting is to exchange information, clear up any misunderstanding and, if possible, arrive at a resolution of the matter, which may include any action described in paragraph 4.2.2.2. If the matter cannot be resolved, the Vice-Rector (Research) shall form an investigative committee.

The investigative committee

An Investigative Committee shall consist of four members named by the Vice-Rector (Research), at least one of whom shall be a person considered to be a peer of the person(s) accused of misconduct. The Vice-Rector (Research), or his delegate, will act as non-voting chairperson.

Due to the sensitive nature of allegations of fraud, the inquiry phase by the Investigative Committee should be completed within thirty days of the initial written notification of the respondent. If the Investigative Committee anticipates that the established deadline cannot be met, the respondents should be informed of the reasons for the delay and progress to date.

In selecting the members of the Investigative Committee, the Vice-Rector (Research) shall take into account such factors as:

a) the subject matter of the inquiry, and the desirability of committee competence in a specialized area of research;

b) the desirability of including on the Committee persons associated with an affiliated institution or people who are not members of the faculty or not associated with the University of Ottawa;

c) the importance of selecting people who have had no prior involvement in the subject matter of the inquiry;

d) the importance of protecting the reputations of individuals by maintaining confidentiality;

e) the adoption of a specified time period of one hundred and twenty days for the completion of the investigation. However, the Vice-Rector (Research) may acknowledge formally in striking the Ad Hoc Committee that the nature of the case renders the time limit difficult to meet. The ability to complete an investigation within a specified time frame will depend heavily upon factors such as the volume and nature of the research to be reviewed and the degree of cooperation shown by the subject of the investigation. The Vice-Rector (Research) may choose to specify interim reporting to monitor the progress of an investigation.

Actions of the investigative committee

The Committee should aim to review all research with which the individual(s) has(ve) been involved during the period of time considered pertinent in relation to the allegations (but in any case, not longer than five years). A determination will also be made as to the involvement of any abstracts, papers or other methods of scholarly communication. A special audit of accounts may also be performed on the sponsored research of the involved individual(s).

The involved individual(s), any collaborators or supervisor related to the investigation will be given the opportunity to review and comment on a draft of the Report. Their remarks will be included as appendices in the final report. The final report will be forwarded to them for comments before a final recommendation is made.

Subsequent action of the investigative committee

The Investigative Committee, upon reviewing all the elements in the case, will formulate recommendations. If the allegations are substantiated, these recommendations may include the need to:

withdraw all pending relevant publications;

notify editors of publications in which involved research was reported;

redefine the status of the involved staff member(s);

ensure that the unit(s) involved is(are) informed about appropriate practices for promoting the proper conduct of research;

inform the involved individual(s), in writing, of the actions that are taken;

inform any outside funding agency of the results of the inquiry and of the actions to be taken;

recommend that disciplinary action be taken.

The Vice-Rector (Research) will inform the Rector and formulate steps so that the recommendations are carried out, that the involved individual(s) are informed in writing of the actions that are to be taken, and that, where appropriate, any outside funding agency is informed of the results of the inquiry and of the actions which will be taken. In all proceedings and subsequent to a final decision, the University will undertake to assure that those making an allegation in good faith and without demonstrably malicious intent will be protected from reprisals or harassment.